Kornimate/medical-research-clean huggingface dataset:
a study to determine the safety, pharmacokinetics, and pharmacodynamics of dnl343 in participants with amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: this is a phase 1b, multicenter, randomized, placebo-controlled, double-blind study of 28 days, followed by an 18-month open-label extension, designed to evaluate the safety, pharmacokinetics (pk), and pharmacodynamics (pd) of dnl343 in participants with amyotrophic lateral sclerosis (als)

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * diagnosis of sporadic or familial als * ≤ 4 years since als symptom onset * stable doses of approved als treatments (riluzole and/or edaravone) for at least 2 months prior to screening * participants must be able to swallow the study intervention * vital capacity \>50% predicted at screening * women must have been surgically sterilized, be postmenopausal, or for participants of childbearing potential, must not be pregnant, and both the participant and the male partner must use highly effective contraception * men, and sex partner if a woman of childbearing potential, must use highly effective contraception key exclusion criteria: * any history of unstable or poorly controlled psychiatric, endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders * positive serum pregnancy test or currently lactating or breastfeeding * history of malignancy within 5 years * history of clinically significant neurologic disorders other than als

Keywords: als
a-spire heart failure: utilizing health tags to identify patients at risk for hospital readmissions

Conditions: Heart Failure

Summary: to evaluate the use of the spire health tags in heart failure patients to determine the feasibility of capturing signals of respiration, pulse rate, activity, sleep patterns, and stress levels following hf hospitalization.

over 5 million americans suffer from heart failure (hf), and treating hf as a chronic condition is associated with significant costs. in addition, about 24% of the patients discharged with a primary diagnosis of hf are readmitted to the hospital within 30 days, representing a significant public health burden. while there have been efforts to predict and reduce 30-day hospital readmission initiated by the centers for medicare and medicaid services (cms), no studies utilized daily physiologic data from wearables to identify at-risk patients. the overall goal of this proposed pilot feasibility study is to utilize the spire health tags in a heart failure patient population to ascertain the feasibility of capturing appropriate signals of respiration, pulse rate, activity, sleep patterns, and stress levels (calm/focused/tense during the day) for \> 80% of the time in patients following hf hospitalization for a 30-day period. the investigators will do exploratory analysis of the changes in these physiologic variables during a 30-day period following hf hospitalization to identify risk markers that could predict 30-day readmission.

Eligibility criteria:
inclusion criteria: * men and women 18 years of age or older; * admitted for acute heart failure; * expected to be discharged from hospitalization; * able to give consent; * willing to use the spire health tags for 30 days continuously. exclusion criteria: * unable or unwilling to participate in the study.

Keywords: spire health tag
trial of ampakine added to clozapine, olanzapine or risperidone in patients with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the effects of a four-week trial of cx516 900mg tid compared to placebo upon verbal memory, attention and negative symptoms. the ampa receptor positive modulator, cx516, will be added to a stable dose of clozapine, olanzapine or risperidone in inpatients and outpatients with schizophrenia. the trial is intended to extend and replicate results from our previous placebo-controlled pilot trial of cx516 added to clozapine in which the investigators found improvement in memory and attention (moderate-to-large between group effect sizes) and did not observe serious side effects. because the investigators' pilot trial also detected at two-week follow-up persistence of cognitive benefits and emergence of a large therapeutic effect upon negative symptoms, this trial will also repeat clinical and cognitive assessments at follow-up, four weeks after completion of the study medication to evaluate persistence and/or strengthening of effects.


Eligibility criteria:
inclusion criteria: 1. diagnosis of schizophrenia, any subtype 2. ages 18-65 years 3. capable of providing informed consent 4. stable dose of clozapine, olanzapine or risperidone for at least 6 months exclusion criteria: 1. serious medical or neurological illness (unstable cardiac disease, seizure disorder, malignancy, liver or renal impairment, etc.) 2. current substance abuse 3. pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile 4. unable to complete neuropsychological tests 5. history of serious blood dyscrasia requiring discontinuation of clozapine 6. serious suicidal or homicidal risk within the past six months

Keywords: schizphrenia cognition negative symptoms
nivolumab plus epacadostat in combination with chemotherapy versus the extreme regimen in squamous cell carcinoma of the head and neck (checkmate 9na/echo-310)

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to evaluate the safety and efficacy of the combination of nivolumab plus epacadostat in combination with chemotherapy in first-line recurrent or metastatic patients with squamous cell carcinoma of the head and neck (scchn) when compared to the standard of care (extreme regimen).


Eligibility criteria:
inclusion criteria: * histologically confirmed scchn from any of the following primary sites: oral cavity, oropharynx, hypopharynx, and larynx. * must have recurrent or metastatic disease that is not amenable to therapy with curative intent (surgery and/or radiation therapy with or without chemotherapy). * no prior treatment with systemic anti-cancer therapy for scchn unless protocol-defined conditions are met. * eastern cooperative oncology group (ecog) performance status of 0 to1. * measurable disease by computed tomography (ct) or magnetic resonance imaging (mri) per recist v1.1. * documentation of program death ligand-1 (pd-l1) status prior to randomization. exclusion criteria: * recurrent or metastatic carcinoma of the nasopharynx and paranasal sinuses, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histologies (e.g., mucosal melanoma) and scchn of unknown primary origin. * untreated central nervous system (cns) metastases. * carcinomatous meningitis. * active, known or suspected autoimmune disease. * physical and laboratory test findings outside the protocol-defined range.

Keywords: squamous cell carcinoma of the head and neck programmed cell death protein 1 (pd-1) antibody indoleamine 2,3-dioxygenase (ido) inhibitor
efficacy of niv masks in copd

Conditions: COPD

Summary: a randomized controlled pilot study to compare the efficacy and tolerability of a two different niv masks on carbon dioxide in participants with stable chronic obstructive pulmonary disease (copd) with chronic type ii respiratory failure.


Eligibility criteria:
inclusion criteria: * a doctor's diagnosis of copd * ptco2 ≥45mmhg on transcutaneous monitor at baseline measure * oxygen saturation measured by pulse oximetry (spo2) ≥85% * fits the study mask * can tolerate the therapy exclusion criteria: * fev1/fvc ≥70% * body mass index \>35 * hypercapnia considered to be primarily due to obesity hypoventilation syndrome and/or obstructive sleep apnea * any condition which makes niv contra-indicated as per bts guidelines based on clinical judgement
perceptions regarding investigational screening for memory problems in primary care

Conditions: Dementia

Summary: the purpose of this study is to conduct a cross-sectional survey of primary care patients to better understand their perceptions of the risks and benefits of a screen and subsequent diagnostic confirmation of dementia.

the health belief model was used to explore the public's acceptance or enthusiasm for early recognition of dementia. based on this model, prior research and clinical experiences, and a systematic literature review, the prism-pc instrument was developed. the prism-pc items seek to capture both the patient's acceptance of dementia screening and the patient's perception of potential harms and benefits of such screening. the instrument includes questions regarding screening by performance-based questionnaires, blood tests, or brain imaging. the prism-pc instrument includes 50 items that are organized into 8 sets of questions that cover the following areas: a) prior experience with ad (5 items) b) acceptance of screening for ad (6 items) c) acceptance of screening for other conditions (2 items) d) benefits of screening for ad (9 items) e) stigma of screening for ad (10 items) f) impact of screening for ad on independence (6 items) g) suffering of screening for ad (4 items) h) demographics (7 items) excluding section a and h (prior experience with ad and demographics), each item of the six other sections is rated on a 5-point likert scale (strongly agree, agree, don't know, disagree, and strongly disagree). based on the previous prism-pc pilot study (a survey response rate of 80%) and the dementia screening and diagnosis study (screening acceptance rate of 90%, positive dementia screening rate of 20% among participants aged 70 and older, and dementia diagnostic acceptance rate of 50%), a total of 1,500 volunteers will be approached. a random selection of 200 participants will be re-administered the questionnaire within one week to test the short-term temporal stability of their responses (test-retest).

Eligibility criteria:
inclusion criteria: * aged 65 and older * at least one office visit to their primary care physician within the last year * no chart-based diagnosis of dementia or memory problem * willing to sign a consent form to participate in the study exclusion criteria: * does not speak english * too hearing-impaired to hear the informed consent statement or the survey * severe mental illness based on the patient's electronic medical charts

Keywords: diagnosis of dementia perceptions of risk dementia screening
high intensity training for neurological injury using overground exoskeletons in inpatient rehabilitation

Conditions: Spinal Cord Injuries

Summary: the purpose of this study is to see if it's possible to reach high cardiovascular intensity training parameters (exercise at a rate that elevates heart rate to the level recommended for improving strength and endurance) while walking in a wearable robotic exoskeleton. this study will also evaluate if exercising at high intensity will lead to improvement in walking ability. participants in this study will be asked to attend 5 walking training sessions using ekso exoskeleton. there will be two additional sessions, one before and one after the five training sessions. at these two sessions, study participants will be asked to participate in seated balance, walking speed and endurance tests and breathing assessments.

the purpose of this study is to determine the feasibility and potential efficacy to implement high cardiovascular intensity training parameters (70-80% heart rate reserve) with the use of overground wearable robotic exoskeletons in an inpatient rehabilitation setting for locomotor recovery. the second aim is to investigate the potential functional improvements in gait after receiving high-intensity locomotor training with an overground exoskeleton, as measured on the 10-meter walk test and six-minute walk test.

Eligibility criteria:
inclusion criteria: * able to achieve adequate fit within the exoskeleton * diagnosis of cva or motor incomplete sci (ais c or d) * sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit * intact skin on all surfaces in contact with device and load-bearing surfaces * weight \<220 pounds exclusion criteria: * pregnancy * spinal instability * unhealed limb or pelvic fractures or any condition restricting weight-bearing in limbs * diagnosis of other neurological injuries other than cva or sci * uncontrolled spasticity (≥3 on modified ashworth scale) * colostomy * decreased range of motion or contractures in legs (\>10° at hips, knees, or ankles) * uncontrolled autonomic dysreflexia * unresolved deep vein thrombosis * inability to tolerate standing due to cardiovascular issues or orthostatic hypotension * inability to follow 3 step commands * severe comorbidities: active infections, heart, lung, or circulatory conditions * pressure sores, impaired skin integrity * use of mechanical ventilation for respiratory support

Keywords: spinal cord injury high intensity exoskeleton
rc48-adc in adjuvant/salvage treatment of her2 positive non-muscle-invasive bladder cancer

Conditions: Non-muscle Invasive Bladder Cancer

Summary: this study will evaluate the efficacy and safety of intravenous rc48-adc in adjuvant/salvage treatment of her2 positive high-risk non-muscle-invasive bladder cancer.

this study is a multicenter phase ii study, which aims to evaluate the efficacy and safety of intravenous rc48-adc in adjuvant/salvage treatment of her2 positive high-risk non-muscle-invasive bladder cancer.

Eligibility criteria:
inclusion criteria: * be willing and able to provide written informed consent/assent for the trial. * life expectancy ≥12 weeks. * have a histologically-confirmed diagnosis of high-risk non-muscle-invasive (according to 2023 nccn guidelines for bladder cancer) transitional cell carcinoma of the bladder. subjects with tumors of mixed transitional/non-transitional cell histology are allowed, but transitional cell carcinoma must be the predominant histology. * have been treated with adequate bcg therapy and failed (according to 2023 eau guidelines for nmibc, for salvage treatment arm). * have elected not to undergo, or are considered ineligible for radical cystectomy, as determined by the treating surgeon. * have tumor tissues for her2 ihc evaluation and have a her2 expression score of her2 2+ or her2 3+ reviewed by an independent pathologist at the central laboratory. * have a performance status of 0, 1 or 2 on the eastern cooperative oncology group (ecog) performance scale. * demonstrate adequate organ function. * female subjects of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication. * male subjects of childbearing potential (section 5.7.2) must agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy. exclusion criteria: * has muscle-invasive (i.e. t2, t3, t4) locally advanced non-resectable or metastatic urothelial carcinoma. * has concurrent extra-vesical (i.e. urethra, ureter or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium. * is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. * has undergone any intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy/turbt to starting trial treatment. (note: a single dose of intravesical treatment given as part of the most recent cystoscopy/turbt, during the screening period, such as with chemotherapy as per local / regional practices, is acceptable.). * allergic to study therapy. * has a known additional malignancy that has had progression or has required active treatment in the last five years. * has an active autoimmune disease that has required systemic treatment in past 2 years. * have diseases that may interfere with the study treatment or severe and uncontrolled concomitant diseases. * has had an allogeneic tissue/solid organ transplant.
asymptomatic atrial fibrillation and stroke evaluation in pacemaker patients and the atrial fibrillation reduction atrial pacing trial

Conditions: Hypertension; Atrial Fibrillation

Summary: in patients with a standard indication for pacing and no previous history of af, detection of atrial high rate episodes predicts an increased risk of stroke and systemic embolism. overdrive atrial pacing with the af suppression algorithm will reduce the risk of symptomatic af in patients with standard indication for pacing and no previous history of af.


Eligibility criteria:
inclusion criteria 1. age ≥ 65 years 2. history of hypertension requiring pharmacological therapy (≥ 4 weeks of therapy). 3. recent (\< 8 weeks) st. jude medical inc. pacemaker implant (identity® adx dr (model 5386/5380)), icd implant (epic 2 or atlas 2) or other st. jude medical inc. pacemaker or icd with the same capabilities. 4. in pacemaker patients only the primary indication for pacing is sinus or av node disease. exclusion criteria 1. previous documented af, atrial flutter (lasting greater than 5 minutes), or other sustained svt (not including episodes detected by the device) 2. geographic/social or psychiatric factor likely to interfere with follow-up 3. requirement for oral anticoagulation (heart valve, deep vein thrombosis, etc.)

Keywords: atrial fibrillation pacemaker af suppression pacing indications for pacemaker implantation due to sinus node or atrio-ventricular node disease
study of anlotinib with chemoradiation for patients with locally advanced nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: anlotinib was added to tp inductive chemotherapy and definitive chemoradiation in nasopharyngeal carcinoma patients with n2-3 disease with necrosis or/and ecm


Eligibility criteria:
inclusion criteria: 1. newly diagnosed nasopharyngeal carcinoma confirmed by histology/cytology ; 2. n2-3 disease (uicc/ajcc 8th) with necrosis or/and ecm; 3. with sufficient organ and bone marrow function; 4. ecog (eastern us cooperative oncology group) score \< 3 5. with good compliance and cooperation to treatment and follow-up 6. agree to use effective methods of contraception during the study period and within 180 days of the last study administration. exclusion criteria: 1. patients with other malignant tumors diagnosed within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors \[ta (non-invasive tumor), tis (carcinoma in situ) ) and t1 (tumor infiltration basement membrane)\] 2. patients with bleeding events nci-ctc ae v5.0 grade ≥ 3, unhealed wounds, ulcers or fracture; 3. human immunodeficiency virus (hiv) infection or known acquired immunodeficiency syndrome (aids), active hepatitis b (hbv dna ≥ 500 iu / ml), hepatitis c (hcv antibody positive, and hcv rna higher than the detection limit of the analysis method) or co infection with hepatitis b and c. 4. active infection (e.g. intravenous drip of antibiotics, antifungal or antiviral drugs) or fever of unknown origin \>38.5℃ 1 weeks ago (except for tumor related fever determined by researchers). 5. abnormal coagulation (inr \> 1.5 or aptt \> 1.5 × uln), bleeding tendency or undergoing thrombolysis or anticoagulation. long term anticoagulation with warfarin or heparin or long-term antiplatelet therapy is required. 6. serious physical or mental illness or laboratory abnormalities may increase the risk of participating in the study 7. allergy to the drugs in the study
safety study of pi-0824 to treat pemphigus vulgaris

Conditions: Pemphigus Vulgaris

Summary: the purpose of this study is to determine if the use of pi-0824 in patients with pemphigus vulgaris is safe.

pemphigus vulgaris (pv) is an autoimmune disease affecting approximately 40,000 people worldwide. people with pv produce antibodies that attack the cells of the skin, resulting in blisters which, if left untreated, can lead to devastating infections and discomfort. currently, most doctors who treat patients with pv will prescribe high-dose steroids and drugs that suppress the immune system in an effort to decrease the production of these antibodies. unfortunately these medications are associated with serious and difficult side effects that often result in the discontinuation of their use. peptimmune, inc. has developed a new therapy for the treatment of pv, pi-0824. the goal of this therapy is to reduce the production of antibodies that cause pv blisters by acting only on the disease causing components of the immune system. it is hoped that use of pi-0824 will reduce or potentially eliminate the need for high dose steroids and drugs that suppress the immune system.

Eligibility criteria:
currently experiencing a stable disease course and medication regimen. currently taking daily corticosteroid therapy for pv.
efficacy of interscalene brachial plexus block with liposomal bupivacaine for arthroscopic shoulder surgery

Conditions: Shoulder Pain; Rotator Cuff Tear

Summary: the purpose of this study is to compare the quality and duration of pain relief after shoulder surgery provided by a single injection of liposomal bupivacaine versus standard bupivacaine when administered as an interscalene brachial plexus block. it is hypothesized that the liposomal bupivacaine formulation will provide more effective pain relief than standard bupivacaine.


Eligibility criteria:
inclusion criteria: * english speaking adults (age \>17 years) of american society of anesthesiologists (asa) i-iii physical class scheduled for elective arthroscopic shoulder surgery will be eligible to participate regardless of race/ethnicity. exclusion criteria: * subjects will not be eligible for this trial if they report a history of an allergy to a local anesthetic, baseline neurological deficit, a medical condition that would make it difficult to assess sensory distribution or communicate with the staff, a recent history (\< 3 months) of drug or alcohol abuse, concomitant opioid therapy, or a preexisting coagulation disorder.

Keywords: exparel liposomal bupivacaine arthroscopic shoulder surgery